Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity (AIS)

Cytrellis

Status

Completed

Conditions

Facial and Neck Skin Laxity

Wrinkle

Treatments

Device: micro-excisional skin removal with coring needle

Study type

Interventional

Funder types

Industry

Identifiers

NCT03228641

700-00001

Details and patient eligibility

About

A pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology for treatment of facial wrinkles. MC device employs hollow coring needles that enable safe, rapid, and effective full-thickness small skin cores (200-500 microns in diameter) removal initiating a skin repair process through formation of new collagen and elastin fibers (skin rejuvenation).

Full description

This is a prospective, multi-center, randomized, single blind, bilateral paired study evaluating the safety, tolerability and preliminary effectiveness of a micro-coring device for removal of excess skin using 2 needle gauges (22G, 24G,) at densities (percent of skin removed per 1cm2) of 2.5-10% in subjects with mid- and lower- face skin laxity manifested by moderate-to-severe mid and lower cheek wrinkles, deepening of the nasolabial folds at rest; prominence of marionette lines at rest; downturn of the oral commissures at rest, sagging of the skin at the jawline at rest. Subjects are blinded to needle gauge and density.

There will be two cohorts of subjects: one group of subjects will receive a single treatment and the second - multiple treatments. All subjects will be followed for 180 days with several intermediate visits at 3, 7, 30, 60, and 90-days.

Enrollment

33 patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Fitzpatrick Skin Type 1, 2, or 3 as assessed by Investigator
One or more of the following conditions assessed by Investigator using provided Severity Scales:
- Nasolabial fold severity at rest ≥2 and ≤4;
- Marionette line prominence at rest ≥2 and ≤4;
- Oral commissure drooping at rest ≥2 and ≤4;
- Jawline sagging at rest ≥2 and ≤4 .
- Moderate-to-Severe wrinkles at rest at least in one of the following areas - the upper lip, chin and cheeks.

Exclusion criteria

Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
History of keloid formation or hypertrophic scarring
History of trauma or surgery to the treatment areas in the past 6 months
Scar present in the areas to be treated
Silicone or synthetic material injections in the areas to be treated
Injection of FDA-approved dermal fillers in the past two years
Injection of fat in the past year
History of treatment with dermabrasion, ablative laser, or radiofrequency in the past year
History of treatment with non-ablative laser in the past 6 months
History of treatment with botulinum toxin injections in the areas to be treated within the prior 6 months
Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment
Active, chronic, or recurrent infection
History of compromised immune system or currently being treated with immunosuppressive agents
History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine
Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
History or presence of any clinically significant bleeding disorder
Co-morbid condition that in the Investigator's opinion could limit ability to participate in the study or to comply with follow-up requirements
History of drug and/or alcohol abuse
Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent
Treatment with an investigational device or agent within 30 days before treatment or during the study period